TECNIS IOL ZCT300 (REF ZCT300U230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474553385), received between Oct 24, 2016 and Aug 6, 2019 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON HAD A CASE WHERE THE OUTCOME WAS OFF FROM EXPECTATION AFTER IMPLANTING TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT300 +23.0 DIOPTER) INTO PATIENT¿S RIGHT EYE. REPORTEDLY THE LENS WAS SCHEDULED TO BE EXPLANTED ON (B)(6) 2019 IN SECONDARY SURGICAL PROCEDURE, HOWEVER AFTER SEVERAL ATTEMPTS OF FOLLOW UP, EXPLANT WAS NOT CONFIRMED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8863136 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZCT300 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO MYOPIC OUTCOME. AT EXPLANT THE INCISION WAS ENLARGED, AND THE EXPLANTED LENS WAS EXCHANGED FOR ANOTHER ZCT300 LENS BUT A LOWER DIOPTER (21.0). REPORTEDLY, THE PATIENT IS DOING GOOD POST OPERATIVELY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8685718 ↗
• InjuryApr 2, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT300 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) OPERATIVE EYE ON (B)(6) 2018. IT WAS DISCOVERED THAT THE LENS HAS ROTATED TO SOME DEGREES AND THE SURGEON WILL TRY TO ROTATE THE LENS. HOWEVER, ANOTHER TORIC EXCHANGE WILL TAKE PLACE IF THE ROTATION IS NOT SUCCESSFUL. THE SURGEON WANTS TO MAKE SURE HE HAS A ZCT300 +23.50/+24.00 ON HAND IF NECESSARY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8472261 ↗
• MalfunctionApr 5, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT TECNIC TORIS INTRAOCULAR LENS (IOL) WAS PLACED AT 165* DEGREES AT SURGERY ON (B)(6) 2017 AND WAS MEASURED AT THE 6-MONTH VISIT ON (B)(6)2018 AT 180 DEGREES (15 DEGREES DIFFERENCE). IT WAS NOTED THAT THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY. THE LENS REMAINS IMPLANTED. THE PATIENT IS DOING WELL AND THE OUTCOME IS NOT INTERFERING WITH DAILY ACTIVITIES. THERE WAS NO PATIENT COMPLICATION AND/OR RELATED INJURY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7398507 ↗
• InjuryMar 16, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) ROTATED AFTER IMPLANTATION. REPORTEDLY, THE SURGEON WAS PLANNING ON KEEPING THE LENS IN THE PATIENT''S EYE AND REPOSITIONING THE LENS IN A SECONDARY SURGICAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT THE LENS ROTATED BY 20 DEGREES AND IT WAS REPOSITIONED ON (B)(6) 2017. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6412055 ↗
• InjuryOct 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT300 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO A REFRACTIVE SURPRISE. A 2.6MM INCISION WAS NEEDED. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED. NO PATIENT INJURY WAS REPORTED. THE LENS WAS REPLACED WITH A ZCT225 21.0 DIOPTER.

  Patient problems: No Code Available

  MAUDE report 6052949 ↗